More particularly, the formula of betaine is (CH.sub.3).sub.3 N.sup.+ CH.sub.2 COO.sup.-. Betaine is known to be naturally present in many plants, especially sugar beets. Also, betaine is known to be naturally present in the kidneys of mammals, and, in particular, is one of the major renal organic osmolytes. See, for instance, Moeckel and Lien, American Journal of Physiology, Vol. 266, No. 3, Part 2 (March, 1994). Additionally, betaine is known to be naturally present as an organic osmolyte in the renal cortex and medullary cones of adult female domestic fowl. See, for instance, Lien, Pacelli, and Braun, "Characterization of Organic Osmolytes in Avian Renal Medulla: A Nonurea Osmotic Gradient System", American Journal of Physiology, Vol. 264, No. 6, Part 2 (June, 1993).
Moreover, a tablet containing betaine HCl, and also containing multiple digestive enzymes such as diastase, is sold under the trade name PREVENZYNE.RTM. from Legere Pharmaceuticals of Scottsdale, Ariz., and under the trade name ZYPAN.RTM. from Standard Process Laboratories, Inc. of Milwaukee, Wis., for the treatment in humans of flatulence, bloating, and fullness after eating food.
Of interest vis-a-vis methylamines such as betaine is U.S. Pat. No. 5,182,299, issued Jan. 26, 1993, to Gullans and Heilig, assignors to Brigham and Women's Hospital of Boston, Mass. More particularly, this patent involves a method of treating an osmotic disturbance in an animal by administering to the animal an organic osmolyte. The osmotic disturbances described are hyponatremia, chronic hyponatremia, central pontine myelinolysis associated with hyponatremia, osmotic disturbances associated with renal dialysis, diabetic ketoacidosis, hyperglycemic hyperosmolar coma, acute hypernatremia, chronic uremia, chronic hypernatremia, including accidental salt loading in high sodium dialysis or baby formula, diabetes insipidus, diabetes mellitus, alcoholism-related dehydration, dehydration from other causes, and AIDS. Diarrhea is not mentioned in the patent.
The '299 patent suggests that three classes of osmolyte compounds are useful in the method of treating an osmotic disturbance in an animal. The three classes are polyols, methylamines, and amino acids. However, only Laboratory Example VI in the '299 patent shows treatment of animals, but it is not treatment of live animals, as there are no laboratory examples of treatment of actual, live animals. Rather, slices of rabbit brain tissue were treated, and moreover, the treatment was only with myoinositol (a type of polyol) and/or with glutamine (a type of amino acid). There is no laboratory example showing either treatment of a live animal or of a tissue sample from a dead animal with a methylamine. The remainder of the laboratory examples do not show any kind of treatment, but rather show the natural presence of various osmolytes in certain tissues from rats and rabbits. Hence, there is no actual reduction to practice of the suggested treatment of live animals for osmotic disturbances. The patent only claims polyols in the method of treating an osmotic disturbance in an animal.
Of further interest in connection with betaine is a case study report by Ilan, Eid, Rivkind, Weiss, Dubin, and Yatziv, entitled "Gastrointestinal Involvement in Homocystinuria", published in the Journal of Gastroenterology and Hepatology, Vol. 8, No. 1, pp. 60-62 (January-February, 1993). In this case study, a young man of 17 years age having a genetic defect known as a cystathionine beta-synthase deficiency, which causes homocystinuria, developed the symptoms of chronic diarrhea and acute pancreatitis. The young man was treated with betaine which alleviated the diarrhea. Betaine, as noted in this article, is known as a methyl donor for the treatment of homocystinuria in beta-synthase deficient patients. In other words, the treatment of the patient with betaine was the treatment of his beta-synthase deficiency, which resulted in the deficiency no longer causing the symptom of diarrhea.
Moreover, betaine has been investigated for the treatment of perosis (hemorrhages and swelling of the hock that leads to a twisted metatarsal joint and slippage of the achilles tendon from the condyle) in chickens. See, McGinnis, Norris, and Heuser, "Effect of Ethanolamine and Betaine on Perosis in Chicks", Proc. Soc. Exp. Biol. Med., Vol. 51, pp. 293-294 (1942). Also, betaine has been investigated for its effect on the growth of chickens. See, Almquist and Grau, "Growth-Promoting Activity of Betaine in the Chick", J. Bio. Chem., Vol. 149, pp. 575-576 (1943); Almquist and Grau, "Interrelationship of Methionine, Choline, Betaine, and Arsenocholine in the Chick", J. Nutr., Vol. 27, pp. 263-269 (1944); and Saunderson and Mackinlay, "Changes in body-Weight, Composition and Hepatic Enzyme Activities in Response to Dietary methionine, Betaine and Choline Levels in Growing chicks", Br. J. Nutr., Vol 63, pp. 339-349 (1990). It is additionally interesting to note that betaine has been shown to reduce coccidiosis lesion score in the guts of broiler chickens.